Safety Study of Colonoscopy Under Sedation (KALINAG)
This study has been terminated.
(This study was stopped due to low inclusion)
Sponsor:
Assistance Publique - Hôpitaux de Paris
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00930358
First received: June 29, 2009
Last updated: April 5, 2011
Last verified: April 2011
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Purpose
The aim of this study was to compare the analgesia provided by nitrous oxide/oxygen sedation or general anesthesia for colonoscopy
| Condition | Intervention | Phase |
|---|---|---|
|
Colonoscopy Procedure |
Drug: MEOPA Drug: general anaesthesia |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Tolerance and Acceptability of Colonoscopy Under Sedation by an Equimolar Mixture of Oxygen and Nitrous Oxide. Comparison With General Anesthesia in a Randomized, Multicentric Study. |
Resource links provided by NLM:
Further study details as provided by Assistance Publique - Hôpitaux de Paris:
Primary Outcome Measures:
- Percentage of patients who have well tolerated the colonoscopy as assessed by visual analogic scale (>75/100) [ Time Frame: Immediately after the colonoscopy ] [ Designated as safety issue: Yes ]
- The mean grade of patient anxiety before endoscopy [ Time Frame: After the colonoscopy ] [ Designated as safety issue: Yes ]The mean grade of patient anxiety before endoscopy
Secondary Outcome Measures:
- The mean tolerability of the colonoscopy between the group with sedation by nitrous oxide/oxygen mixture and the group with anesthesia [ Time Frame: after the colonoscopy ] [ Designated as safety issue: Yes ]
- The mean pain intensity during the procedure on a visual analogic scale [ Time Frame: after the colonoscopy ] [ Designated as safety issue: Yes ]
- The mean patient satisfaction on a visual analogic scale. [ Time Frame: after the colonoscopy ] [ Designated as safety issue: Yes ]
- The percentage of patients who agree to repeat the procedure in similar circumstances. [ Time Frame: after the colonoscopy ] [ Designated as safety issue: Yes ]
- The grade of difficulty of the colonoscopy evaluated by the endoscopist [ Time Frame: After the colonoscopy ] [ Designated as safety issue: Yes ]
- The mean duration of the endoscopy [ Time Frame: After the colonoscopy ] [ Designated as safety issue: Yes ]
- The percentage of caecum intubation [ Time Frame: After the colonoscopy ] [ Designated as safety issue: Yes ]
- The percentage of ileal intubation [ Time Frame: After the colonoscopy ] [ Designated as safety issue: Yes ]
- The opinion of the endoscopist on the tolerance of the colonoscopy [ Time Frame: After the colonoscopy ] [ Designated as safety issue: Yes ]
- The time to hospital discharge [ Time Frame: After the issue of the colonoscopy ] [ Designated as safety issue: Yes ]
- The Aldrete's score at the hospital discharge [ Time Frame: After the colonoscopy ] [ Designated as safety issue: Yes ]
- The number of patient who have refused the inclusion [ Time Frame: After the issue of the colonoscopy ] [ Designated as safety issue: No ]
| Enrollment: | 220 |
| Study Start Date: | February 2009 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: MEOPA
MEOPA : equimolar nitrous oxide/oxygen mixture
|
Drug: MEOPA
anaesthetic gaz inhalation
Other Name: anaesthetic gaz inhalation
|
|
Active Comparator: General anesthesia
Gold standard
|
Drug: general anaesthesia
Anaesthetic intravenous route
Other Name: Anaesthetic intravenous route
|
Detailed Description:
The purpose of this protocol is to compare two methods of analgesia/sedation for colonoscopy. Sedation and analgesia induced by a 50% nitrous oxide/oxygen mixture could sufficient to allow the practice of colonoscopy instead of general anesthesia which is accompanied with certain risks and post procedure drowsiness.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient referred for colonoscopy with general anesthesia
- Age above 18 et below 75 year
- Patient who gave an informed consent
Exclusion Criteria:
- Age below 18 ou above 75
- Need for gastroscopy in the same procedure than colonoscopy
- History of surgery wih resection more extended than half of the colon
- Dementia with autonomy loss or psychiatric disorder non controlled by therapeutic
- Severe congestive heart failure or evolutive heart ischemia
- Recent cerebral stroke
- Hemodynamic instability
- Respiratory failure, severe chronic obstructive pulmonary (including asthma) or progressive pneumothorax
- Hepatic failure (Child-Pugh score> 9)
- Terminal renal failure 11 Hematopoietic disorders
12. Pathology with expected survival shorter than the duration of the study and cancer excepted basal cell carcinoma of the skin 13. Alcohol consumption higher than 100 gr per day 14. Pregnancy or breastfeeding at the inclusion period
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00930358
Locations
| France | |
| Hotel Dieu Hospital | |
| Paris, France, 75004 | |
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
| Principal Investigator: | Dominique Lamarque, MD, PhD | Assistance Publique - Hôpitaux de Paris |
More Information
Publications:
| Responsible Party: | Cécile Kedzia, Department Clinical Research of Developpement |
| ClinicalTrials.gov Identifier: | NCT00930358 History of Changes |
| Other Study ID Numbers: | P060240 |
| Study First Received: | June 29, 2009 |
| Last Updated: | April 5, 2011 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Sedation Colonoscopy General anesthesia |
Additional relevant MeSH terms:
|
Anesthetics Nitrous Oxide Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anesthetics, Inhalation Anesthetics, General |
ClinicalTrials.gov processed this record on May 21, 2013